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Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658905
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : November 3, 2014
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

Brief Summary:
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.

Condition or disease Intervention/treatment Phase
Replacement Therapy in Preterm Infants Drug: rhBSSL Drug: Placebo Phase 2

Detailed Description:
In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Infant Formula Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age
Study Start Date : April 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: rhBSSL Drug: rhBSSL
0.15 g/L rhBSSL added to infant formula; one week treatment
Other Name: bucelipase alfa (INN)

Placebo Comparator: Placebo Drug: Placebo
One week treatment

Primary Outcome Measures :
  1. Coefficient of Fat Absorption in stool [ Time Frame: Stool collected for a 72-hour period during the final 3 days of each treatment period ]

Secondary Outcome Measures :
  1. Change in length and body weight between the start and end of each treatment period [ Time Frame: Baseline and after one week of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Preterm infants
  • less than or equal to 32 weeks of gestational age
  • appropriate for gestational age
  • enterally fed with infant formula

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00658905

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Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi
Ancona, Italy
Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale
Bari, Italy
3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS
Milano, Italy
4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
Padova, Italy
Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
Rome, Italy
U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva
Rome, Italy
Sponsors and Collaborators
Swedish Orphan Biovitrum
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Study Director: Kristina Timdahl, MD Biovitrum AB

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Swedish Orphan Biovitrum Identifier: NCT00658905     History of Changes
Other Study ID Numbers: BVT.BSSL-020
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014
Keywords provided by Swedish Orphan Biovitrum:
Preterm infants
Replacement therapy
Infant formula
BSSL is present in fresh mother's milk but not in infant formula.
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications